BC43 Inter-amer 30

     
BW20020903002231  20020903T130743Z UTC


( BW)(ELI-LILLY)(BC43) Tadalafil for the Treatment of Erectile
Dysfunction Receives Positive Recommendation From the Australian Drug
Evaluation Committee

    Business Editors
    UK REGULATORY NEWS

    INDIANAPOLIS--(BUSINESS WIRE)--Sept. 3, 2002--

Eli Lilly and Company (NYSE: LLY) announced today that the Australian
Drug Evaluation Committee (ADEC) has issued a positive recommendation
for tadalafil, an investigational oral PDE5 inhibitor for the
treatment of erectile dysfunction (ED).

Following the recommendation by ADEC, approval of tadalafil in
Australia is subject to final authorization by the Therapeutic Goods
Administration (TGA), the regulatory body responsible for the
evaluation of new therapies in Australia. The TGA considers the advice
and recommendation provided by ADEC when making its final decision.

"We are extremely pleased by ADEC's positive recommendation for
tadalafil," said Lorenzo Tallarigo, president, intercontinental
operations, Lilly. "This positive action by ADEC is a significant
milestone, as it indicates that the approval of tadalafil in Australia
is near and that millions of men affected by ED may soon have a new
oral treatment choice."

In Australia, at least one-third of men over 50 suffer from ED.(1),(2)

ADEC based its recommendation on the review and evaluation of more
than 60 studies that enrolled more than 4,000 people to characterize
the safety and efficacy profile of tadalafil. The committee is
comprised of doctors appointed to advise on the suitability of drugs
for marketing in Australia.

Requests for marketing approval for tadalafil are currently pending in
more than 30 countries worldwide. Tadalafil is currently going through
the European Commission decision-making process after having received
a positive opinion from the Committee for Proprietary Medicinal
Products in July 2002. It is also under review by the U.S. FDA and
received an approvable letter in April 2002.

Upon approval in North American and European countries, tadalafil will
be launched in these markets by Lilly ICOS LLC, a joint venture
between Eli Lilly and Company and ICOS Corporation that was formed in
1998 to develop, manufacture and market tadalafil. In Australia and
various other markets worldwide, Lilly will market tadalafil.

About Erectile Dysfunction

ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. ED affects an estimated
152 million men and their partners worldwide.(3) Up to 80 percent of
ED cases are caused by physiological conditions, including
cardiovascular disease and diabetes, with psychological factors
accounting for the remaining 20 percent. In many cases, however, both
psychological and physical factors contribute to the condition.(4)

About Lilly

Eli Lilly and Company, a leading innovation-driven corporation, is
developing a growing portfolio of best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Indiana, Lilly provides
answers - through medicines and information - for some of the world's
most urgent medical needs. Additional information about Lilly is
available at www.lilly.com.

(1) Pinnock CB, Stapleton AMF, Marshall VR. Erectile Dysfunction in
the Community: a prevalence study. The Medical Journal of Australia
1999, 171 (7): 353-357

(2) Chew KK, Earle CM, Stuckey BGA, Jamrozick K, Keogh EJ. Erectile
dysfunction in general medicine practice: prevalence and clinical
correlates. Int. J. Impotence Research 2000, 12: 41-45

(3) Aytac et al. BJU International, 1999:84:50-56

(4) www.impotence.org.uk

   Short Name: Lilly (Eli) & Co
   Category Code: MSC
   Sequence Number: 00000726
   Time of Receipt (offset from UTC): 20020829T011150+0100

    --30--db/in

    CONTACT: Eli Lilly and Company
             Angela Sekston, 317/277-8503
              or
             Jane Calloway, 317/651-5870
             www.lilly.com

    KEYWORD: INDIANA UNITED KINGDOM AUSTRALIA INTERNATIONAL ASIA
PACIFIC EUROPE
    INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICAL PHARMACEUTICAL PRODUCT 
    SOURCE: Lilly (Eli) & Co

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